These tests can be used to demonstrate compliance with the requirements for seal strength of ISO 11607 - "Packaging for terminally sterilized medical devices - Part 1".
The burst strength of a flexible pack is determined by pressurizing the package until it bursts. The position and type (seal or material) of failure is recorded in addition to the burst pressure value. Alternatively the resistance to creep failure at a specified hold pressure can be determined.
Smithers employs a Lippke 4500 Package Testing System for burst and pressure decay integrity testing. A burst test can be performed restrained (ASTM F2054) or unrestrained (ASTM F1140).
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